FDA extends PDUFA goal date for Apellis' EMPAVELI Injector sNDA

Apellis Pharmaceuticals, Inc.

FDA notified Apellis on March 14, 2023 that labeling review is ongoing and the March 15, 2023 PDUFA goal date will be missed.
New PDUFA goal date for the EMPAVELI Injector (for PNH self-administration) has not yet been determined.
EMPAVELI (pegcetacoplan) is currently approved for adults with paroxysmal nocturnal hemoglobinuria.
The injector is an on-body device designed to enhance self-administration of EMPAVELI.

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